Clinical trials: Dialysis
Obstructive Lesions of Arteriovenous Dialysis Fistulae
Study of NMB (Company's Name) Drug Ejecting Balloon for Arteriovenous Fistulae
The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) Balloon.
- Trial name
- NCT01538108
- Testing
- PTA Balloon catheter with paclitaxel, Plain Balloon angioplasty (PBA)
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- N.M.B. Medical Applications Ltd
Anemia
A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia.
- Trial name
- NCT00737464
- Testing
- methoxy polyethylene glycol-epoetin beta [Mircera]
- Where
- 17 sites in India
- Volunteers
- 132 people
- Sponsor
- Hoffmann-La Roche
Healthy, Renal Impairment
Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Single Dose Lacosamide in Subjects With Renal Impairment Compared to Healthy Subjects
To investigate the Pharmacokinetics (PK) of oral administered Lacosamide in renal impaired subjects and healthy subjects.
- Trial name
- NCT01796938
- Testing
- Lacosamide tablet
- Where
- 2 sites in Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- UCB BIOSCIENCES GmbH
Anemia
FG-4592 for Treatment of Anemia in Subjects With Chronic Kidney Disease
This is a randomized, multicenter, open-label, active-controlled study of the treatment of anemia in subjects with CKD on dialysis, with treatment up to 52 weeks.
- Trial name
- NCT02652806
- Testing
- FG-4592, Epoetin Alfa
- Where
- 31 sites in China
- Volunteers
- 305 people
- Sponsor
- Kyntra Bio
Kidney Disease
Study to Evaluate Effectiveness of Aranesp®
The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).
- Trial name
- NCT00117130
- Testing
- Aranesp®
- Sponsor
- Amgen
Chronic Kidney Disease
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)
The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
- Trial name
- NCT01469078
- Testing
- Monofer®
- Volunteers
- 18 people
- Sponsor
- Pharmacosmos A/S
End Stage Renal Disease
Carry Life@ UF System Clinical Study
The Carry Life UF system performs peritoneal ultrafiltration by adding glucose to the low glucose strength (1.36%) peritoneal dialysis fluid which has been instilled into the peritoneal cavity prior to the connection of the…
- Trial name
- NCT05874804
- Testing
- Carry Life UF, 2.27% glucose peritoneal dialysis dwell
- Where
- 11 sites in Italy, Sweden and 1 more
- Volunteers
- 28 people
- Sponsor
- Triomed AB
Hemodialysis
Ex Vivo Microbiological Assessment of an Anti-biofilm Catheter in Acute Dialysis Application
The clinical study aims at providing data on antimicrobial efficiency and a supposed additional preventive effect on catheter-related infections of a catheter with antibacterial surface coating in comparison to standard catheters…
- Trial name
- ABBA (NCT00621114)
- Testing
- GamCath® central venous catheter, GamCath Dolphin® Protect central venous catheter
- Where
- Germany
- Volunteers
- 69 people
- Sponsor
- Vantive Health LLC
Peritoneal Dialysis, Chronic Kidney Disease
Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis
The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis.
- Trial name
- NCT00196755
- Testing
- Sevelamer Hydrochloride (Renagel®), Calcium acetate (PhosLo® )
- Where
- 17 sites in Belgium, Denmark and 5 more
- Volunteers
- 138 people
- Sponsor
- Genzyme, a Sanofi Company
Chronic Hepatitis C
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic…
- Trial name
- SOF/VEL ESRD (NCT03036852)
- Testing
- SOF/VEL
- Where
- 22 sites in Australia, Canada and 4 more
- Volunteers
- 59 people
- Sponsor
- Gilead Sciences
Anemia, Dialysis Dependent Chronic Kidney Disease
Dose-Finding Study of Vadadustat in Japanese Subjects With Anemia Secondary to Dialysis-Dependent Chronic Kidney Disease (DD-CKD)
This is a Phase 2, randomized, double-blind, placebo-controlled, dose-finding study to assess the efficacy, safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of orally administered vadadustat in Japanese…
- Trial name
- NCT03054350
- Testing
- Vadadustat
- Where
- 18 sites in Japan
- Volunteers
- 60 people
- Sponsor
- Akebia Therapeutics
End-stage Renal Disease, Kidney Failure, Chronic
Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With ESRD
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.
- Trial name
- NCT01744418
- Testing
- HAVG graft implantation
- Where
- 3 sites in Poland
- Volunteers
- 40 people
- Sponsor
- Humacyte, Inc.
Hemodialysis Patients
Detection of Lung Pathologies Among Dialysis Patients Using Pulsenmore MC™ Device - Feasibility Study
PRIMARY OBJECTIVE: To measure success rate and identification of pathological lung B-lines, using novel mobile Self-scan ultrasound device (MC, by Pulsenmore), in chronic renal failure patients, pre and post dialysis.
- Trial name
- NCT07028060
- Testing
- PulseNmore MC™
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- PulseNmore
Anemia
Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients
The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.
- Trial name
- NCT00721188
- Testing
- Venofer
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- American Regent, Inc.
Hyperphosphatemia, ESRD
Phosphate Kinetic Modeling 2
The study aims to investigate the concept of computer based Phosphate Kinetic Modeling (PKM) in the hemodialysis patient population.
- Trial name
- PKM2 (NCT01252771)
- Testing
- PKM Algorithm
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- Fresenius Medical Care North America
Renal Insufficiency / Therapy
PD Catheter Data Collection
Peritoneal Dialysis (PD) is a Renal Replacement Therapy for patients with renal insufficiency that has been used more frequently in recent years.
- Trial name
- Catheter (NCT07156123)
- Where
- 2 sites in Germany
- Volunteers
- 300 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Kidney Disease, Peritoneal Dialysis (PD)
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
To explore the use of the Bodyport Cardiac Scale in predicting worsening of events due to fluid overload in patients with kidney disease on peritoneal dialysis.
- Conditions
- Kidney Disease, Peritoneal Dialysis (PD), End Stage Kidney Disease (ESRD)
- Trial name
- SCALE-PD (NCT07059962)
- Testing
- Bodyport Cardiac Scale
- Where
- 7 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Bodyport Inc.
Kidney Failure, Chronic, Renal Dialysis
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
The purpose of this this study is to investigate the clinical utility of renal denervation in the treatment of ESRD patients with refractory hypertension.
- Trial name
- NCT00753116
- Testing
- Renal Denervation with a catheter-based procedure
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medtronic Vascular
Healthy
Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects
The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered…
- Trial name
- NCT02412449
- Testing
- AKB-6548 tablet, reference formulation given in the fasted state, AKB-6548 tablet, test formulation given in the fasted state., AKB-6548 tablet, test formulation given in the fed state
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Akebia Therapeutics
Dialysis Catheter Infections
Efficacy Study to Evaluate B-Lock™ as an Antimicrobial Lock Solution in Dialysis Patients With a CVC
Hypothesis: B-Lock is a safe and effective catheter lock solution that will maintain catheter patency and reduce Central Line Associated Blood Stream Infections (CLABSI) in dialysis patients using a central venous catheter (CVC)…
- Trial name
- NCT01989091
- Testing
- B-Lock, Heparin 5,000 U/mL
- Where
- 21 sites in Hungary, Poland
- Volunteers
- 270 people
- Sponsor
- Great Lakes Pharmaceuticals Inc.